Medicare Advantage

Medical Policy

Notification

Direct Endoscopic Necrosectomy (DEN) for the Treatment of Pancreatic Necrosis

Notification Issued Date:

Title:

Direct Endoscopic Necrosectomy (DEN) for the Treatment of Pancreatic Necrosis

Policy #:

MA11.115

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Direct endoscopic necrosectomy (DEN) is considered medically necessary and, therefore, covered for treatment of pancreatic necrosis in adult individuals when all of the following criteria are met:

The individual has failed to show improvement following at least 4 weeks of standard medical treatment including percutaneous or endoscopic drainage
Fluid collection has to be mature
Wall of the fluid collection has to be adjacent to the gastric or duodenal wall
Fluid collection has to be about 6 cm or larger in size

EXPERIMENTAL/INVESTIGATIONAL

DEN using the EndoRotor Powered Endoscopic Debridement System is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

There is no Medicare coverage determination addressing direct endoscopic

necrosectomy (DEN) for the treatment of pancreatic necrosis; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, DEN is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Subject to the terms and conditions of the applicable Evidence of Coverage, DEN using the

EndoRotor Powered Endoscopic Debridement System is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are excluded for the Company’s Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The

EndoRotor Powered Endoscopic Debridement System was approved by the FDA on December 23, 2020, to resect and remove necrotic tissue in symptomatic walled off pancreatic necrosis/walled off necrosis (WOPN/WON) after having undergone endoscopic ultrasound (EUS)-guided drainage.

Description

Acute pancreatitis is one of the most frequently diagnosed gastrointestinal diseases requiring hospitalization. Walled-off pancreatic necrosis (WOPN) is a complication of acute pancreatitis that develops 4 weeks or longer after the acute illness (

Boumitri et al., 2017;

Mohy-

ud-din and Morrissey, 2024). It is estimated that 20% of all acute pancreatitis individuals develop necrotizing pancreatitis and approximately 33% of those progress to infected necrosis. Conservative management of infected necrosis is rarely effective, and most require surgical management. The traditional approach to infected WOPN has long been primary laparotomy with complete debridement of pancreatic and peripancreatic necrosis. This surgical approach of primary "open necrosectomy" is associated with a high risk of complications and death.

In the last decade, minimally invasive procedures, such as percutaneous drainage, video-assisted retroperitoneal drainage, endoscopic ultrasound-guided transluminal drainage, and, when necessary, direct endoscopic necrosectomy (DEN) have gained popularity (van der

Wiel et al., 2020). Recent guidelines now advocate the use of a step-up approach, consisting of catheter drainage followed, only if necessary, by necrosectomy. The aim of catheter drainage as a first step is to temporize sepsis by releasing infected fluid from the peripancreatic collections. This may improve the individual's clinical condition and thereby postpone or even obviate the need for further intervention. Catheter drainage can be performed percutaneously under guidance of ultrasound or computed tomography, or

endoscopically through the wall of the stomach or duodenum. If the individual’s clinical condition does not improve after catheter drainage, necrosectomy can be performed through laparotomy, laparoscopy, a minimally invasive retroperitoneal approach or by an endoscopic transluminal approach. DEN is a complex procedure requiring multiple passes through the endoscope to dissect and remove the necrotic tissue from the WOPN cavity (

Rizzatti et al., 2020).

DIRECT ENDOSCOPIC NECROSECTOMY (DEN)

DEN was first described in a series of individuals in whom transluminal stent placement had failed (Seifert et al., 2000). Initially, this procedure was performed by balloon dilation of the

cystenterostomy tract (up to 20 mm) after double-pigtail plastic stent (DPPS) placement with subsequent debridement of necrotic tissue. The currently favored approach is to perform DEN through the lumen of the lumen-apposing metal stent (LAMS) used to create the

cystenterostomy, either concurrent with walled-off necrosis (WON) drainage or in a delayed approach if transluminal stent drainage alone fails to resolve the WON (

Rerknimitr, 2020). This delayed approach allows for transmural tract maturation before DEN (

Rerknimitr, 2020) and, if resolution of WON occurs, may obviate the need for DEN (

Nemoto et al., 2017; Rana et al., 2017;

Lakhtakia et al., 2017).

A large multicenter retrospective study (n=271) compared immediate DEN (n=69) with delayed DEN (n=202) performed 1 week after the initial LAMS-assisted drainage procedure (Yan et al., 2019). Clinical success was the same in each group (91.3% immediate compared with 86.1% delayed; P=0.3); however, the immediate DEN group required fewer necrosectomy sessions (3.1 vs 3.9; P<0.001). Additionally, no significant difference was seen in the overall procedural adverse events (AEs) between the two groups (7.2% vs 9.4%; P=0.81). Stent dislodgement during the index endoscopy occurred in three individuals in the immediate DEN group compared with no individuals in the delayed DEN group (P=0.016).

SOCIETY GUIDELINES AND POSITION PAPERS

AMERICAN COLLEGE OF GASTROENTEROLOGY (ACG)

In 2024, the American College of Gastroenterology (ACG) published a guideline addressing the management of individuals with acute pancreatitis (Tenner et al., 2024). The guideline made the following recommendations:

"Minimally invasive methods are preferred to open surgery for debridement and necrosectomy in stable individuals with symptomatic pancreatic necrosis"
"We suggest delaying any intervention (surgical, radiological, and/or endoscopic) in stable individuals with pancreatic necrosis, preferably 4 wk, to allow for the wall of collection to mature"

AMERICAN GASTROENTEROLOGICAL ASSOCIATION (AGA)

In 2020, the American Gastroenterological Association (AGA) published a Clinical Practice Update addressing the management of pancreatic necrosis (Baron et al., 2020). The purpose of this update was to review the available evidence and expert recommendations regarding the clinical care of individuals with pancreatic necrosis and to offer concise best practice advice for the optimal management of individuals with this condition. The AGA made the following recommendations:

"The use of direct endoscopic necrosectomy should be reserved for those individuals with limited necrosis who do not adequately respond to endoscopic transmural drainage using large-bore, self-expanding metal stents/lumen-apposing metal stents alone or plastic stents combined with irrigation. Direct endoscopic necrosectomy is a therapeutic option in individuals with large amounts of infected necrosis, but should be performed at referral centers with the necessary endoscopic expertise and interventional radiology and surgical backup."
"A step-up approach consisting of percutaneous drainage or endoscopic transmural drainage using either plastic stents and irrigation or self-expanding metal stents/lumen-apposing metal stents alone, followed by direct endoscopic necrosectomy, and then surgical debridement is reasonable, although approaches may vary based on the available clinical expertise."

EUROPEAN SOCIETY OF GASTROINTESTINAL ENDOSCOPY (ESGE)

In 2018, the European Society of Gastrointestinal Endoscopy (ESGE) published a guideline addressing endoscopic management of acute necrotizing pancreatitis (

Arvanitakis et al., 2018). ESGE made the following recommendations:

"ESGE recommends invasive intervention for individuals with acute necrotizing pancreatitis and clinically suspected or proven infected necrosis. Strong recommendation, low quality evidence."
"ESGE suggests that the first intervention for infected necrosis should be delayed for 4 weeks if tolerated by the individual. Weak recommendation, low quality evidence."
"ESGE recommends performing endoscopic or percutaneous drainage of (suspected) infected walled-off necrosis as the first interventional method, taking into account the location of the walled-off necrosis and local expertise. Strong recommendation, moderate quality evidence."
"ESGE suggests that, in the absence of improvement following endoscopic transmural drainage of walled-off necrosis, endoscopic necrosectomy or minimally invasive surgery (if percutaneous drainage has already been performed) is to be preferred over open surgery as the next therapeutic step, taking into account the location of the walled-off necrosis and local expertise. Weak recommendation, low quality evidence."

EASTERN ASSOCIATION FOR THE SURGERY OF TRAUMA (EAST)

In 2017, the Eastern Association for the Surgery of Trauma (EAST) published a practice management guideline addressing the surgical management of pancreatic necrosis (Mowery et al., 2017). The practice management guideline made the following recommendations:

In adult individuals with pancreatic necrosis, does early surgery compared with late surgery decrease mortality rates?

"The panel determined that the quality of evidence was low overall; we also considered that most patients would place a high value on the potential 50% reduction in mortality seen with delaying surgery. Although the exact number of how long to delay is in question, it would appear that delaying at least 12 days and potentially 30 days would lead to additional decreases in mortality. This allows for a strong recommendation due to patient preference. Thus, in adult patients with pancreatic necrosis, we recommend that pancreatic necrosectomy should be delayed until at least day 12, as opposed to earlier necrosectomy."

In adult individuals undergoing surgery for pancreatic necrosis, do minimally invasive approaches compared with open approaches decrease the mortality rate?

"The overall quality of evidence was rated as low. The panel considered that most patients would place a high value on the potential three-fold reduction in postoperative organ failure and 50% reduction in mortality. This allows for a strong recommendation.

"In adult patients with pancreatic necrosis, even documented infected necrosis, we recommend that patients undergo a step-up approach to surgical intervention. This includes aggressive use of percutaneous drains as a means to delay or even definitively treat necrosis which may be the real benefit of this surgical pathway rather than the actual surgical incision. This recommendation is based on low-quality evidence and is associated with significant patient benefit."

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE (NICE)

In 2016, the National Institute for Health and Care Excellence (NICE) published evidence-based recommendations on endoscopic transluminal pancreatic necrosectomy in adults (NICE, 2016). NICE made the following recommendations:

"Current evidence on the safety of endoscopic transluminal pancreatic necrosectomy shows that there are serious but well‑recognised complications. Evidence on efficacy is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit."
"Patient selection should be done by a multidisciplinary team experienced in the management of the condition."
"Endoscopic transluminal pancreatic necrosectomy should only be done in a specialist centre by a team experienced in the management of complex pancreatic disease."

In 2011, NICE published evidence-based recommendations on percutaneous retroperitoneal endoscopic necrosectomy (NICE, 2011). NICE made the following recommendations:

"Current evidence on the safety and efficacy of percutaneous retroperitoneal endoscopic necrosectomy is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit."
"The procedure should only be carried out by a team experienced in the management of complex pancreatic disease."

INTERNATIONAL ASSOCIATION OF PANCREATOLOGY (IAP)/AMERICAN PANCREATIC ASSOCIATION (APA)

In 2013, the International Association of Pancreatology (IAP) and the American Pancreatic Association (APA) published an evidence-based guideline addressing the management of acute pancreatitis (Working Group IAP/APA Acute Pancreatitis Guidelines, 2013). The guideline made the following recommendations:

Indications for intervention in necrotizing pancreatitis

"Common indications for intervention (either radiological, endoscopical or surgical) in necrotizing pancreatitis are: 1) Clinical suspicion of, or documented infected necrotizing pancreatitis with clinical deterioration, preferably when the necrosis has become walled-off, 2) In the absence of documented infected necrotizing pancreatitis, ongoing organ failure for several weeks after the onset of acute pancreatitis, preferably when the necrosis has become walled-off. (GRADE 1C, strong agreement)"
"Routine percutaneous fine needle aspiration of peripancreatic collections to detect bacteria is not indicated, because clinical signs (i.e., persistent fever, increasing inflammatory markers) and imaging signs (i.e., gas in peripancreatic collections) are accurate predictors of infected necrosis in the majority of individuals. Although the diagnosis of infection can be confirmed by fine needle aspiration (FNA), there is a risk of false-negative results. (GRADE 1C, strong agreement)"
"Indications for intervention (either radiological, endoscopical or surgical) in sterile necrotizing pancreatitis are: 1) Ongoing gastric outlet, intestinal, or biliary obstruction due to mass effect of walled-off necrosis (i.e., arbitrarily >4-8 weeks after onset of acute pancreatitis), 2) Persistent symptoms (e.g., pain, ‘persistent unwellness’) in individuals with walled-off necrosis without signs of infection (i.e. arbitrarily >8 weeks after onset of acute pancreatitis), 3) Disconnected duct syndrome (i.e. full transection of the pancreatic duct in the presence of pancreatic necrosis) with persisting symptomatic (e.g., pain, obstruction) collection(s) with necrosis without signs of infections (i.e., arbitrarily >8 weeks after onset of acute pancreatitis). (GRADE 2C, strong agreement)"

Timing of intervention in necrotizing pancreatitis

"For patients with proven or suspected infected necrotizing pancreatitis, invasive intervention (i.e. percutaneous catheter drainage, endoscopic transluminal drainage/necrosectomy, minimally invasive or open necrosectomy) should be delayed where possible until at least 4 weeks after initial presentation to allow the collection to become ‘walled-off’. (GRADE 1C, strong agreement)"
"The best available evidence suggests that surgical necrosectomy should ideally be delayed until collections have become walled-off, typically 4 weeks after the onset of pancreatitis, in all patients with complications of necrosis. No subgroups have been identified that might benefit from earlier or delayed intervention. (GRADE 1C, strong agreement)"

Intervention strategies in necrotizing pancreatitis

"The optimal interventional strategy for patients with suspected or confirmed infected necrotizing pancreatitis is initial image-guided percutaneous (retroperitoneal) catheter drainage or endoscopic transluminal drainage, followed, if necessary, by endoscopic or surgical necrosectomy. (GRADE 1A, strong agreement)"
"Percutaneous catheter or endoscopic transmural drainage should be the first step in the treatment of patients with suspected or confirmed (walled-off) infected necrotizing pancreatitis. (GRADE 1A, strong agreement)"
"There are insufficient data to define subgroups of patients with suspected or confirmed infected necrotizing pancreatitis who would benefit from a different treatment strategy. (GRADE 2C, strong agreement)"

ENDOROTOR POWERED ENDOSCOPIC DEBRIDEMENT SYSTEM

The

EndoRotor Powered Endoscopic Debridement System (

Interscope Medical, Inc.) is a novel automated mechanical endoscopic system indicated to resect and remove necrotic tissue in symptomatic walled-off pancreatic necrosis/walled-off necrosis (WOPN/WON) after having undergone endoscopic ultrasound (EUS) guided drainage. The

EndoRotor received clearance for marketing in the United States through the US Food and Drug Administration (FDA) Premarket Notification Process on January 3, 2019 (FDA, K181127). The Class II device was assigned Product Code PTE (Endoscopic

Morcellator Gastroenterology). On December 23, 2020, the

EndoRotor Powered Endoscopic Debridement System was reclassified under a de novo reclassification request and assigned Product Code QNE (Endoscopic Pancreatic Debridement Device) (FDA, DEN200016).

The

EndoRotor Powered Endoscopic Debridement System is designed to overcome some of the limitations of DEN, which before now has been performed without visualization using generic, nondedicated instruments to cut, grasp, and retrieve the necrotic tissue (

Rizzatti et al., 2020). The

EndoRotor Powered Endoscopic Debridement System catheter is placed within the necrotic cavity and, through its central channel, targeted tissue is debrided and aspirated under continuous endoscopic visualization (

Rizzatti et al., 2020; van der

Wiel et al., 2020).

According to the reclassification order issued by the FDA's de novo pathway (FDA, DEN200016), an endoscopic pancreatic debridement device is inserted through an endoscope and, via a

cystogastrostomy fistula, enters the WOPN cavity where it is used to resect and debride the necrotic tissue in the pancreatic cavity. The device has an inner and outer cutter with a permanently attached lavage and aspiration tubing and a customized trap where specimens are collected.

The evidence base evaluating the

EndoRotor Powered Endoscopic Debridement System consists of one systematic review/meta-analysis (

Ramai et al., 2024), four case series (

Fahmawi et al., 2020; Morris et al., 2029;

Rizzatti et al., 2020; van der

Wiel et al., 2020), one retrospective cohort study (

Soota et al., 2020), and two prospective, multicenter studies (Shinn et al., 2022; Stassen et al., 2022). The size of the four case series studies ranged from three to 12 individuals. The retrospective cohort study included four individuals, and the two prospective, multicenter studies included 23 individuals (Shin et al., 2022) and 30 individuals (Stassen et al., 2022).

The systematic review and meta-analysis performed by

Ramai et al. (2024) included all of the studies listed above. Outcomes of interest included technical success defined as successful use of the

EndoRotor Powered Endoscopic Debridement System, clinical success defined as complete debridement of pancreatic tissue, and procedure-related AEs. Mortality was also evaluated. The authors reported the following:

The pooled cumulative rate of clinical success was 96% (95% confidence interval [CI], 91%–100%, I2 = 0%) with a pooled cumulative technical success rate of 96% (91%–100%, I2 = 0%). The pooled cumulative procedure-related AE rate was 8% (2%–14%, I2 = 6%).
The subtypes of AEs were procedure-associated bleeding, pneumoperitoneum, peritonitis, pleural effusion, and LAMS dislodgement or entanglement, and stent perforation.
Four individuals died of a cause unrelated to the EndoRotor Powered Endoscopic Debridement System.
A sensitivity analysis revealed that "no single study significantly affected the primary outcomes".
Minimal heterogeneity was found in the pooled event rates of technical success, clinical success, and AEs. Further subgroup analysis and/or meta-regression analysis was not possible because of the limited study sample size.
A publication bias analysis was not performed, as the total number of studies included in the final analysis was less than 10.

The authors noted the following limitations to their study:

The included studies were not entirely representative of the general population and community practice
The analysis included studies that were retrospective in nature, contributing to selection bias
The authors were not able to directly compare their results with other endoscopic methods for treating WON because of no available studies comparing EndoRotor Powered Endoscopic Debridement System to other endoscopic methods.

The evidence base evaluating the use of the

EndoRotor Powered Endoscopic Debridement System to resect and remove necrotic tissue in symptomatic WOPN/WON consists of small,

noncomparative studies. No studies were identified comparing the

EndoRotor Powered Endoscopic Debridement System to other endoscopic methods. Large comparative studies, preferably randomized controlled trials, are needed to determine if the

EndoRotor Powered Endoscopic Debridement System is as effective as other established endoscopic methods.

References

Abu Dayyeh BK, Topazian M. Endoscopic management of pancreatic necrosis. Am J Gastroenterol. 2018;113(9):1269-1273.

Ang TL. Current Status of Direct Endoscopic Necrosectomy. Proceedings of Singapore Healthcare. 2012;21(3):179-186.

Ang TL, Kwek AB, Tan SS, et al. Direct endoscopic necrosectomy: a minimally invasive endoscopic technique for the treatment of infected walled-off pancreatic necrosis and infected pseudocysts with solid debris. Singapore Med J. 2013;54(4):206-211.

Arvanitakis M, Dumonceau JM, Albert J, et al. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018;50(5):524-546.

ASGE Standards of Practice Committee; Muthusamy VR, Chandrasekhara V, Acosta RD, et al. The role of endoscopy in the diagnosis and treatment of inflammatory pancreatic fluid collections. Gastrointest Endosc. 2016;83(3):481-438.

Bang JY, Lakhtakia S, Thakkar S, et al; United States Pancreatic Disease Study Group. Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial. Lancet Gastroenterol Hepatol. 2024;9(1):22-33.

Bang JY, Wilcox CM, Arnoletti JP, et al. Superiority of endoscopic interventions over minimally invasive surgery for infected necrotizing pancreatitis: meta-analysis of randomized trials. Dig Endosc. 2020;32(3):298-308.

Bang JY, Wilcox CM, Hawes R, et al. Outcomes of a Structured, Stepwise Approach to Endoscopic Necrosectomy. J Clin Gastroenterol. 2021;55(7):631-637.

Bang JY, Wilcox CM, Trevino J, et al. Factors impacting treatment outcomes in the endoscopic management of walled-off pancreatic necrosis. J Gastroenterol Hepatol. 2013;28(11):1725-1732.

Baron TH, DiMaio CJ, Wang AY, et al. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020;158(1):67-75.e1.

Boumitri C, Brown E, Kahaleh M. Necrotizing Pancreatitis: Current Management and Therapies. Clin Endosc. 2017;50(4):357-365.

Brown NG, Sethi A. Endoscopic Drainage of Pancreatic Fluid Collections. Gastrointest Endosc Clin N Am. 2024;34(3):553-575.

Cirocchi R, Trastulli S, Desiderio J, et al. Minimally invasive necrosectomy versus conventional surgery in the treatment of infected pancreatic necrosis: a systematic review and a meta-analysis of comparative studies. Surg Laparosc Endosc Percutan Tech. 2013;23(1):8-20.

Dorrell R, Pawa S, Pawa R. Endoscopic Management of Pancreatic Fluid Collections. J Clin Med. 2021;10(2):284.

Fahmawi Y, Loeb L, Hanjar A, et al. S3494 “Cave Monster Stealing Jobs”: Studying the efficacy of a modernistic device in necrotizing pancreatitis: Case series. Am J Gastroenterol. 2020;115:S1811.

Feng L, Guo J, Wang S, et al. Endoscopic Transmural Drainage and Necrosectomy in Acute Necrotizing Pancreatitis: A Review. J Transl Int Med. 2021;9(3):168-176.

Fogel EL. Endoscopic pancreatic necrosectomy. J Gastrointest Surg. 2011;15(7):1098-1100.

Gardner TB, Chahal P, Papachristou GI, et al. A comparison of direct endoscopic necrosectomy with transmural endoscopic drainage for the treatment of walled-off pancreatic necrosis. Gastrointest Endosc. 2009;69(6):1085-1094.

Gardner TB, Coelho-Prabhu N, Gordon SR, et al. Direct endoscopic necrosectomy for the treatment of walled-off pancreatic necrosis: results from a multicenter U.S. series. Gastrointest Endosc. 2011;73(4):718-726.

Garg R, Gupta S, Singh A, et al. Hydrogen peroxide assisted endoscopic necrosectomy for walled-off pancreatic necrosis: A systematic review and meta-analysis. Pancreatology. 2021;21(8):1540-1547.

Gjeorgjievski M, Bhurwal A, Chouthai AA, et al. Percutaneous endoscopic necrosectomy (PEN) for treatment of necrotizing pancreatitis: a systematic review and meta-analysis. Endosc Int Open. 2023;11(3):E258-E267.

Goldenberg DE, Gordon SR, Gardner TB. Management of acute pancreatitis. Expert Rev Gastroenterol Hepatol. 2014;8(6):687-694.

Gurusamy KS, Belgaumkar AP, Haswell A, et al. Interventions for necrotising pancreatitis. Cochrane Database Syst Rev. 2016;4(4):CD011383.

Haghshenasskashani A, Laurence JM, Kwan V, et al. Endoscopic necrosectomy of pancreatic necrosis: a systematic review. Surg Endosc. 2011;25(12):3724-3730.

Haney CM, Kowalewski KF, Schmidt MW, et al. Endoscopic versus surgical treatment for infected necrotizing pancreatitis: a systematic review and meta-analysis of randomized controlled trials. Surg Endosc. 2020;34(6):2429-2444.

Heinrich S, Schäfer M, Rousson V, et al. Evidence-based treatment of acute pancreatitis: a look at established paradigms. Ann Surg. 2006;243(2):154-168.

Hollemans RA, Timmerhuis HC, Besselink MG, et al. Long-term follow-up study of necrotising pancreatitis: interventions, complications and quality of life. Gut. 2024;73(5):787-796.

Hollemans RA, van Brunschot S, Bakker OJ, et al.; Dutch Pancreatitis Study Group. Minimally invasive intervention for infected necrosis in acute pancreatitis. Expert Rev Med Devices. 2014;11(6):637-648.

Jagielski M, Chwarścianek A, Piątkowski J, et al. Percutaneous Endoscopic Necrosectomy-A Review of the Literature. J Clin Med. 2022;11(14):3932.

Jearth V, Rana SS. Endoscopic step up: When and how. Surg Open Sci. 2022;10:135-144.

Jha AK, Goenka MK, Kumar R, et al. Endotherapy for pancreatic necrosis: An update. JGH Open. 2018;3(1):80-88.

Kamal F, Khan MA, Lee-Smith WM, et al. Early versus late endoscopic treatment of pancreatic necrotic collections: A systematic review and meta-analysis. Endosc Int Open. 2023;11(9):E794-E799.

Kaul V, Diehl D, Enslin S, et al. Safety and efficacy of a novel powered endoscopic debridement tissue resection device for management of difficult colon and foregut lesions: first multicenter U.S. experience. Gastrointest Endosc. 2021;93(3):640-646.

Khan MA, Kahaleh M, Khan Z, et al. Time for a Changing of Guard: From Minimally Invasive Surgery to Endoscopic Drainage for Management of Pancreatic Walled-off Necrosis. J Clin Gastroenterol. 2019;53(2):81-88.

Kim YS, Cho JH, Cho DH, et al. Long-term Outcomes of Direct Endoscopic Necrosectomy for Complicated or Symptomatic Walled-Off Necrosis: A Korean Multicenter Study. Gut Liver. 2021;15(6):930-939.

Kumar N, Conwell DL, Thompson CC. Direct endoscopic necrosectomy versus step-up approach for walled-off pancreatic necrosis: comparison of clinical outcome and health care utilization. Pancreas. 2014;43(8):1334-1339.

Lakhtakia S, Basha J, Talukdar R, et al. Endoscopic "step-up approach" using a dedicated biflanged metal stent reduces the need for direct necrosectomy in walled-off necrosis (with videos). Gastrointest Endosc. 2017;85(6):1243-1252.

Law R, Baron TH. Endoscopic management of pancreatic pseudocysts and necrosis. Expert Rev Gastroenterol Hepatol. 2015;9(2):167-175.

Leppäniemi A, Tolonen M, Tarasconi A, et al. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019;14:27.

Luigiano C, Pellicano R, Fusaroli P, et al. Pancreatic necrosectomy: an evidence-based systematic review of the levels of evidence and a comparison of endoscopic versus non-endoscopic techniques. Minerva Chir. 2016;71(4):262-269.

Mahapatra SJ, Garg PK. Percutaneous Endoscopic Necrosectomy. Gastrointest Endosc Clin N Am. 2023;33(4):737-751.

Mendoza Ladd A, Bashashati M, Contreras A, et al. Endoscopic pancreatic necrosectomy in the United States-Mexico border: A cross sectional study. World J Gastrointest Endosc. 2020;12(5):149-158.

Messallam AA, Adler DG, Shah RJ, et al. Direct Endoscopic Necrosectomy With and Without Hydrogen Peroxide for Walled-off Pancreatic Necrosis: A Multicenter Comparative Study. Am J Gastroenterol. 2021;116(4):700-709.

Mohan BP, Madhu D, Toy G, et al. Hydrogen peroxide-assisted endoscopic necrosectomy of pancreatic walled-off necrosis: a systematic review and meta-analysis. Gastrointest Endosc. 2022;95(6):1060-1066.

Mohy-ud-din N, Morrissey S. Pancreatitis. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024.

Morris L, Geraghty J, Makin A. PWE-071 EndoRotor® use to manage walled-off pancreatic necrosis; first UK experience. Gut. 2019;68:A160.

Mowery NT, Bruns BR, MacNew HG, et al. Surgical management of pancreatic necrosis: A practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2017;83(2):316-327.

Nakai Y, Shiomi H, Hamada T, et al; WONDERFUL study group in Japan. Early versus delayed interventions for necrotizing pancreatitis: A systematic review and meta-analysis. DEN Open. 2022;3(1):e171.

National Institute for Health and Care Excellence (NICE). Endoscopic transluminal pancreatic necrosectomy [IPG567]. November 23, 2016. Available at: https://www.nice.org.uk/guidance/ipg567. Accessed October 21, 2024.

National Institute for Health and Care Excellence (NICE). Percutaneous retroperitoneal endoscopic necrosectomy [IPG384]. March 23, 2011. Available at: https://www.nice.org.uk/guidance/ipg384. Accessed October 21, 2024.

Nemoto Y, Attam R, Arain MA, et al. Interventions for walled off necrosis using an algorithm based endoscopic step-up approach: Outcomes in a large cohort of patients. Pancreatology. 2017;17(5):663-668.

Onnekink AM, Boxhoorn L, Timmerhuis HC, et al.; Dutch Pancreatitis Study Group. Endoscopic Versus Surgical Step-Up Approach for Infected Necrotizing Pancreatitis (ExTENSION): Long-term Follow-up of a Randomized Trial. Gastroenterology. 2022;163(3):712-722.e14.

Orr J, Yachimski P. Timing of Endoscopic Necrosectomy Following Transmural Stent Placement for Pancreatic Necrosis. Curr Treat Options Gastroenterol. 2018;16(4):622-625.

Pannala R, Ross AS. Pancreatic endotherapy and necrosectomy. Curr Treat Options Gastroenterol. 2015;13(2):185-197.

Pawa R, Dorrell R, Clark C, et al. Delayed endoscopic necrosectomy improves hospital length of stay and reduces endoscopic interventions in patients with symptomatic walled-off necrosis. DEN Open. 2022;3(1):e162.

Pinto S, Bellizzi S, Badas R, et al. Direct Endoscopic Necrosectomy: Timing and Technique. Medicina (Kaunas). 2021;57(12):1305.

Psaltis E, Varghese C, Pandanaboyana S, et al. Quality of life after surgical and endoscopic management of severe acute pancreatitis: A systematic review. World J Gastrointest Endosc. 2022;14(7):443-454.

Puli SR, Graumlich JF, Pamulaparthy SR, et al. Endoscopic transmural necrosectomy for walled-off pancreatic necrosis: a systematic review and meta-analysis. Can J Gastroenterol Hepatol. 2014;28(1):50-53.

Ramai D, Ahmed Z, Chandan S, et al. Safety and efficacy of the EndoRotor device for the treatment of walled-off pancreatic necrosis after EUS-guided cystenterostomy: A systematic review and meta-analysis. Endoscopic Ultrasound. 2024;13(3):165-170.

Ramai D, McEntire DM, Tavakolian K, et al. Safety of endoscopic pancreatic necrosectomy compared with percutaneous and surgical necrosectomy: a nationwide inpatient study. Endosc Int Open. 2023;11(4):E330-E339.

Ramai D, Morgan AD, Gkolfakis P, et al. Endoscopic management of pancreatic walled-off necrosis. Ann Gastroenterol. 2023;36(2):123-131.

Rana SS, Sharma V, Sharma R, et. Endoscopic ultrasound guided transmural drainage of walled off pancreatic necrosis using a "step-up" approach: A single centre experience. Pancreatology. 2017;17(2):203-208.

Rerknimitr R. Endoscopic Transmural Necrosectomy: Timing, Indications, and Methods. Clin Endosc. 2020;53(1):49-53.

Rizzatti G, Rimbas M, Impagnatiello M, et al. Endorotor-Based Endoscopic Necrosectomy as a Rescue or Primary Treatment of Complicated Walled-off Pancreatic Necrosis. A Case Series. J Gastrointestin Liver Dis. 2020;29(4):681-684.

Rosenberg A, Steensma EA, Napolitano LM. Necrotizing pancreatitis: new definitions and a new era in surgical management. Surg Infect (Larchmt). 2015;16(1):1-13.

Sagar AJ, Khan M, Tapuria N. Evidence-Based Approach to the Surgical Management of Acute Pancreatitis. Surg J (N Y). 2022;8(4):e322-e335.

Sameera S, Mohammad T, Liao K, et. Management of Pancreatic Fluid Collections: An Evidence-based Approach. J Clin Gastroenterol. 2023;57(4):346-361.

Saumoy M, Trindade AJ, Bhatt A, et al. Endoscopic therapies for walled-off necrosis. iGIE. 2023;2(2):226-239.

Seifert H, Wehrmann T, Schmitt T, et al. Retroperitoneal endoscopic debridement for infected peripancreatic necrosis. Lancet. 2000;356(9230):653-635.

Shah A, Denicola R, Edirisuriya C, et al. Management of Inflammatory Fluid Collections and Walled-Off Pancreatic Necrosis. Curr Treat Options Gastroenterol. 2017;15(4):576-586.

Shah RJ. Endoscopic interventions for walled-off pancreatic fluid collections. February 22, 2024. Available at: www.uptodate.com. Accessed November 11, 2024.

Shinn B, Burdick JA, Berk K, et al. Safety, efficacy and clinical utility of the 5.1 mm EndoRotor powered debridement catheter for treatment of walled-off pancreatic necrosis. Gastrointest Endosc. 2022;95:AB235-AB236.

Soota K, Abdelfatah M, Peter S, et al. Experience with Endorotorxt for endoscopic necrosectomy in patients with acute necrotic pancreatitis at a tertiary care center. Endoscopy. 2020;52:ePP223.

Stassen PMC, de Jonge PJF, Bruno MJ, et al. Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointest Endosc. 2022;95(3):471-479.

Storm AC, Thompson CC. Safety of direct endoscopic necrosectomy in patients with gastric varices. World J Gastrointest Endosc. 2016;8(10):402-408.

Strand DS, Law RJ, Yang D, et al. AGA Clinical Practice Update on the Endoscopic Approach to Recurrent Acute and Chronic Pancreatitis: Expert Review. Gastroenterology. 2022;163(4):1107-1114.

Tang P, Ali K, Khizar H, et al. Endoscopic versus minimally invasive surgical approach for infected necrotizing pancreatitis: a systematic review and meta-analysis of randomized controlled trials. Ann Med. 2023;55(2):2276816.

Tenner S, Baillie J, DeWitt J, et al. American College of Gastroenterology Guideline: Management of Acute Pancreatitis. Am J Gastroenterol. 2013;108(9):1400-15;1416.

Tenner S, Vege SS, Sheth SG, et al. American College of Gastroenterology Guidelines: Management of Acute Pancreatitis. Am J Gastroenterol. 2024;119(3):419-437.

Thompson CC, Kumar N, Slattery J, et al. A standardized method for endoscopic necrosectomy improves complication and mortality rates. Pancreatology. 2016;16(1):66-72.

Timmerhuis HC, Ngongoni RF, Li A, et al. The Potential Clinical Benefits of Direct Surgical Transgastric Pancreatic Necrosectomy for Patients With Infected Necrotizing Pancreatitis. Pancreas. 2024;53(7):e573-e578.

Trikudanathan G, Tawfik P, Amateau SK, et al. Early (<4 Weeks) Versus Standard (≥ 4 Weeks) Endoscopically Centered Step-Up Interventions for Necrotizing Pancreatitis. Am J Gastroenterol. 2018;113(10):1550-1558.

Trikudanathan G, Yazici C, Evans Phillips A, et al. Diagnosis and Management of Acute Pancreatitis. Gastroenterology. 2024;167(4):673-688.

Troncone E, Amendola R, Gadaleta F, et al. Indications, Techniques and Future Perspectives of Walled-off Necrosis Management. Diagnostics (Basel). 2024;14(4):381.

Tyberg A, Karia K, Gabr M, et al. Management of pancreatic fluid collections: A comprehensive review of the literature. World J Gastroenterol. 2016;22(7):2256-2270.

U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). EndoRotor. 510(k) summary [K170120]. [FDA Web site]. 04/18/2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170120. Accessed October 10, 2024.

U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control. 510(k) summary [K181127]. [FDA Web site]. 01/03/2019. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181127. Accessed October 10, 2024.

U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). EndoRotor Device. De Novo Classification Order and Decision Summary (DEN200016). [FDA Web Site]. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200016. Accessed October 10, 2024.

van Brunschot S, Bakker OJ, Besselink MG, et al.; Dutch Pancreatitis Study Group. Treatment of necrotizing pancreatitis. Clin Gastroenterol Hepatol. 2012;10(11):1190-1201.

van Brunschot S, Fockens P, Bakker OJ, et al. Endoscopic transluminal necrosectomy in necrotising pancreatitis: a systematic review. Surg Endosc. 2014;28(5):1425-1438.

van Brunschot S, Hollemans RA, Bakker OJ, et al. Minimally invasive and endoscopic versus open necrosectomy for necrotising pancreatitis: a pooled analysis of individual data for 1980 patients. Gut. 2018;67(4):697-706.

van Brunschot S, van Grinsven J, van Santvoort HC, et al.; Dutch Pancreatitis Study Group. Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial. Lancet. 2018;391(10115):51-58.

van Brunschot S, van Grinsven J, Voermans RP, et al.; Dutch Pancreatitis Study Group. Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]. BMC Gastroenterol. 2013;13:161.

van der Wiel SE, May A, Poley JW, et al. Preliminary report on the safety and utility of a novel automated mechanical endoscopic tissue resection tool for endoscopic necrosectomy: a case series. Endosc Int Open. 2020;8(3):E274-E280.

Vyawahare MA, Gulghane S, Titarmare R, et al. Percutaneous direct endoscopic pancreatic necrosectomy. World J Gastrointest Surg. 2022;14(8):731-742.

Willems P, Varadarajulu S. Endoscopic Ultrasound Guided Walled-off Necrosis Drainage. Gastrointest Endosc Clin N Am. 2023;33(4):725-735.

Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013;13(4 Suppl 2):e1-15.

Yamamoto N, Isayama H, Takahara N, et al. Percutaneous direct-endoscopic necrosectomy for walled-off pancreatic necrosis. Endoscopy. 2013;45 Suppl 2 UCTN:E44-5.

Yan L, Dargan A, Nieto J, et al. Direct endoscopic necrosectomy at the time of transmural stent placement results in earlier resolution of complex walled-off pancreatic necrosis: Results from a large multicenter United States trial. Endosc Ultrasound. 2019;8(3):172-179.

Zeng Y, Yang J, Zhang JW. Endoscopic transluminal drainage and necrosectomy for infected necrotizing pancreatitis: Progress and challenges. World J Clin Cases. 2023;11(9):1888-1902.

Zhai YQ, Ryou M, Thompson CC. Predicting success of direct endoscopic necrosectomy with lumen-apposing metal stents for pancreatic walled-off necrosis. Gastrointest Endosc. 2022;96(3):522-529.e1.

Zhou X, Lin H, Su X, et al. Metal Versus Plastic Stents for Pancreatic Fluid Collection Drainage: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2021;55(8):652-660.

Coding

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT DIRECT ENDOSCOPIC NECROSECTOMY (DEN):

48999

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

K85.01 Idiopathic acute pancreatitis with uninfected necrosis

K85.02 Idiopathic acute pancreatitis with infected necrosis

K85.11 Biliary acute pancreatitis with uninfected necrosis

K85.12 Biliary acute pancreatitis with infected necrosis

K85.21 Alcohol induced acute pancreatitis with uninfected necrosis

K85.22 Alcohol induced acute pancreatitis with infected necrosis

K85.31 Drug induced acute pancreatitis with uninfected necrosis

K85.32 Drug induced acute pancreatitis with infected necrosis

K85.81 Other acute pancreatitis with uninfected necrosis

K85.82 Other acute pancreatitis with infected necrosis

K85.91 Acute pancreatitis with uninfected necrosis, unspecified

K85.92 Acute pancreatitis with infected necrosis, unspecified

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA11.115:

01/20/2025

This policy will become effective 01/20/2025.

This new policy has been developed to communicate the Company's coverage position and medical necessity criteria for direct endoscopic necrosectomy (DEN) for the treatment of pancreatic necrosis.

Version Effective Date:

1/20/2025

Version Issued Date:

1/20/2025

Version Reissued Date: